Sporium Ophthalmic Emulsion 50ml

Presentation

Sporium Sterile Ophthalmic Emulsion: Each ml contains Cyclosporine USP 0.5 mg

Description

Sporium Sterile Ophthalmic Emulsion is a preparation of Cyclosporine 0.05% which acts as an immunomodulator in patients whose tear production is suppressed due to ocular inflammation associated with keratoconjunctivitis sicca.

Indications

This drug is indicated to increase tear production in patients whose tear production is suppressed due to ocular inflammation associated with dry eye syndrome (keratoconjunctivitis sicca).

Dosage & Administration of Sporium Ophthalmic Emulsion

Instill one drop of this drug twice a day in each eye approximately 12 hours apart. It can be used concomitantly with artificial tears, allowing a 15 minute interval between products

Side Effects of Sporium Ophthalmic Emulsion

The most common adverse event is ocular burning. Other events reported include
conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation,
pruritus, stinging, and visual disturbance (most often blurring).

Precautions

This drug should not be administered while wearing contact lenses. Patients with
decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following the administration of this medication. This drug may cause blurred vision. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Use in Pregnancy & Lactation

Pregnancy category C. There are no adequate and well-controlled studies of
Cyclosporine ophthalmic emulsion in pregnant women. It should be administered to pregnant women if clearly needed.
Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of Cyclosporine ophthalmic emulsion, caution should be exercised when it is administered to a nursing woman.

Contraindication

Cyclosporine is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

Cyclosporine eye drops should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of this formulation. Lenses may be reinserted 15 minutes following administration of Cyclosporine eye drop. Lactation: Excretion in milk unknown; use with caution

Storage 

Keep out of the reach of children.
Keep in a cool and dry place, away from light.
Do not use more than 4 weeks after opening